Suspendable organ transplant system and method of use

ABSTRACT

The present invention relates to organ transplant systems used to keep organs chilled and viable as they are moved between patients. More specifically, the present invention both contains the organ and holds it in position during transplant surgery. Thus, there is no need for a member of the implant surgical team to hold the organ while it is being sewn into place.

BACKGROUND OF THE INVENTION State of the Art

The present invention relates to organ transplant systems used to holdorgans as they are moved between patients.

There are a variety of situations in which organs from one donor areplaced into the body of a recipient, and the number of such proceduresis increasing. According to data from the United Network for OrganSharing (UNOS), for example, more than 400,000 renal transplantationshave been performed since the first successful renal transplantation inthe 1950s. Innovative developments in technique allow organs such as thepancreas to be transplanted in order to correct defects in insulinproduction, restoring insulin production in Type 1 diabetics. Withimproved surgical techniques and immunosuppressive medications, outcomesafter renal and extrarenal (liver, pancreas, lung, heart, pancreas)transplantation have continued to improve.

Most solid-organ transplantations are now performed as the therapeuticoption of choice. In many cases, transplantation offers definitivetreatment for a given disease entity. As a result, the list ofindications for solid-organ transplantation has expanded considerably,placing increasing pressure on an already limited supply of donororgans.

At the same time, a shortage of organs for transplant remains a majorproblem for patients. The number of candidates on the waiting listcontinues to increase each year—close to 60,000 adults were on thekidney waiting list in 2011—while organ donation numbers remain flat.The average waiting time for a deceased donor kidney transplant nowexceeds three years.

Additionally, many organs recovered for transplant are discarded, anddiscard rates are increasing. Living donation rates have beenessentially unchanged for the past decade, despite public donationprograms and awareness campaigns. Not all organs are sufficientlyhealthy for transplant, either due to damage, age, alcohol consumption,or either acute or systemic infection. The organs of individualsinfected with Hepatitis C, for example, cannot be placed into uninfectedrecipients (although ground-breaking new procedures sometimes permitorgans infected with Hepatitis C to be placed in other HepatitisC-positive individuals.)

With such constraints, preservation of organs for transport betweencenters, and preservation of organs during transplantation, becomescrucial. However, the conflict between the need to rapidly remove,transport, and implant organs in order to minimize ischemia time, andthe need to keep manual organ manipulation to a minimum, poses serioustechnical challenges.

Even extremely short periods of manual handling may irreversibly damageorgans. One study found that thirteen minutes of gentle manualmanipulation of rat livers after harvest and before transplantationdecreased survival by 70%, and doubled areas of necrosis. (Schemmer, P.et al., Gentle in situ liver manipulation during organ harvest decreasessurvival after rat liver transplantation: role of Kupffer cells.TRANSPLANTATION 5 1015-20 (Apr. 27, 1998; 65(8))

By contrast, a simple renal transplant procedure, without complications,may take between two and three hours. The kidney to be transplanted mustbe manually held above the incision by one surgeon, while anothersutures the vein, artery, and ureter into place. During this time, theorgan is removed from the chilled solution in which it was transported,and thus may warm, leading to greater tissue death and an increasednumber of cellular changes. Small movements while the organ is beingheld may result in tissue damage, or could tug at newly-placed sutures,and the organ may drip chilled solution onto the patient or into theincision.

Additionally, the surgical incision may be quite small and alreadycrowded by the surgical frame that bolts to the table and holds theincision open. Thus it can be difficult for the two or more surgeons towork comfortably.

Transplant procedures for other organs may take even longer than akidney transplant. Some organs have many attachments, such as veins,arteries, etc., that all must be sutured into correct positions.

Moreover, while an organ is being held, it is exposed to both dry airand potential contaminants. Presently, an organ must be periodicallyre-moistened while it is being held, although this tends to result inmore dripping into the patient's incision.

Further, infection after transplantation is a constant concern, and amajor cause of organ failure. Any infection in a post-operative patientcan greatly extend the length of a hospital stay, and the concurrentrisk of further hospital-acquired (nosocomial) illness. The greatestconcern with early infection is that organisms can infect a graft or itsvascular supply at suture sites, causing mycotic aneurysms ordehiscence. Transplant recipients may take antibiotics for six months ormore after receiving an organ.

Although operating rooms are typically equipped with air handling andventilation systems in order to keep microorganisms to an irreducibleminimum, such rooms are not perfectly sterile. The patient, healthcareworkers, and inanimate objects are all capable of introducingpotentially infectious material onto the surgical field. Operating roomair may contain microbial-laden dust, lint, skin squames, or respiratorydroplets. It has been found that the microbial level in operating roomair is directly proportional to the number of people moving about in theroom, and that contamination risks increase with activities such asmoving, talking, and exposing an organ to the air. Organ transplantsurgeons must therefore work as quickly as possible, balancing speedagainst the need to ensure that grafts are optimally placed andstitched.

In addition to working quickly, surgeons must also make note of everypiece of equipment entering and leaving an operating room, in order toreduce the chances that a sponge, clamp, or other hardware may be leftinside the organ recipient's body cavity.

Thus, there is a need for an organ transplant system and method thatsubstantially minimizes organ handling, while keeping the organoptimally chilled, moistened, and shielded from any contamination. It isdesirable that such an organ transplant system is easy to use, includesfew detachable pieces, and reduces crowding around an incision duringorgan transplant. It is also desirable to provide such an organtransplant system which is disposable, inexpensive, and easy tomanufacture.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an organ transplantsleeve system and method of use which does at least one of reducing thehandling of organs before and during transplantation; holding the organin desired position during grafting, and/or reducing the rate ofinfections during transplant.

The present invention may include a container which both contains theorgan and holds it in position during transplant surgery. The organ'sveins, arteries, nerves, and other connective portions may be freelyaccessible, while the organ itself remains chilled and cushioned in thecontainer. After being sewn into place, the organ can be released fromthe container and placed into the body cavity of the transplantrecipient. Thus, in accordance with one application of the presentinvention, there is no need for a member of the implant surgical team tohold the organ while it is being sewn into place.

In some embodiments, the container is a transplant sleeve which includesa temperature sensor to indicate when the organ should be returned to ahypothermic preservation solution.

Some embodiments feature a connector mechanism which may be latched ontoa Bookwalter® (Symmetry Surgical, Antioch, Tenn.) retractor frame orother surgical retractor frame which holds open a transplant patient'sincision.

According to some aspects of the present disclosure, the connectormechanism may allow the transplant sleeve's elevation above the incisionto be adjusted, in order to bring the organ closer or move it away withprecision. The connector mechanism may also swivel to keep it out of thedoctor's way when suturing on either side of the organ.

Additionally, in some embodiments, the transplant sleeve contains orabsorbs drips of preservation solution, so that the liquid does not fallfrom the organ into the incision where excess fluid might interfere withthe suture procedure.

In some embodiments, the transplant sleeve is perforated, so that theentire sleeve can be pulled open to release the organ, once it is inplace.

According to some aspects of the present disclosure, the bottom andsides of the transplant sleeve may be releasably or slideably opened, torelease the organ once grafting is complete.

In some embodiments, the bottom of the transplant sleeve may be heldtogether by a magnetic strip.

According to some aspects of the present disclosure, the transplantsleeve may be formed as a single piece of any suitable material, as maybe well known in the art, including biocompatible plastics, other typesof flexible synthetic materials or fabrics. A single piece of materialmay reduce the number of small objects used during the surgery, and maymake it significantly easier to confirm remaining equipment after thetransplant surgery. The transplant container or sleeve may betransparent, in order to facilitate visual checks of the organ.

In some embodiments, the transplant sleeve may be glove-shaped. In thisconfiguration, the transplant sleeve may be inserted into the bodycavity of a living individual and placed around an organ in order tochill the organ during surgery. For example, a stopped heart may bechilled while the heart's valves are operated on.

In some embodiments, the transplant sleeve may contain cold packs, inorder to extend the length of time a surgery may safely proceed with aviable organ.

In some embodiments, the transplant sleeve may be disposable, in wholeor in part.

According to one aspect of the present invention, the transplant sleevemay be transparent, in order to facilitate visual checks of the organ,and to aid in locating organ attachments such as veins, arteries, andthe like.

According to another aspect of the present invention, the organtransplant sleeve may substantially prevent bacteria, fungi, or otherorganisms/contaminates from contacting an organ placed inside.

According to another aspect of the present invention, an inner,organ-contacting surface of the organ transplant sleeve may be formed ofa material which limits the ability of bacteria to attach to thematerial, such as a thermoplastic such as poly methyl methacrylate(“PMMA”), cyanoacrylate compounds, or any other suitable material towhich infectious agents have a reduced ability to attach or proliferate.

In one embodiment of the present invention, the organ transplant sleevemay be flexible, in order to accommodate differing sizes of transplantedorgans.

In one embodiment the organ transplant sleeve may be double-walled,allowing a user to access and replace the cooling packs withoutdisturbing the organ.

According to still another aspect of the present invention, the organtransplant sleeve may include ports or openings through which the veins,arteries, and other attachment points of an organ may be accessed,without disturbing or releasing the organ.

According to another aspect of the invention, the organ transplantsleeve may comprise an antibiotic, antifungal, or sterilizing compound.

In accordance with one aspect of the present invention, a method ofreducing the handling of organs before and during transplant maycomprise placing an organ in a compartment, hanging the compartment froma rack, accessing the organ's connecting points, grafting the attachmentpoints in place, and releasing the organ from the compartment.

According to another aspect of the invention, an organ transplant systemmay include tearable components made of a biocompatible andbio-absorbable material such that, if any fragments come loose, thesefragments can be left in the body.

According to still another aspect of the present disclosure, a clip or aslider is disclosed for opening the access ports in order to access anorgan's connecting veins, arteries, or the like.

According to another aspect of the present disclosure, an organtransplant sleeve may be equipped with ports so that coolant may becirculated through the sleeve while the organ is being grafted intoplace.

In still another embodiment, the organ transplant sleeve may beplaceable within the body cavity of an individual, in order to chill anorgan of the individual, while surgical procedures are performed on theindividual. For example, an organ transplant sleeve may be placed aroundthe heart, while the heart's valves are replaced.

These and other aspects of the present invention are realized in asuspended organ transplant sleeve system and method of use as shown anddescribed in the following figures and related description.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention are shown and described inreference to the numbered drawings wherein:

FIG. 1 illustrates one embodiment of the present disclosure, featuring adouble-walled, padded, transplant sleeve, and tearable perforationsthrough which an organ may be removed.

FIGS. 2a, 2b, and 2c illustrate three embodiments of a retractor frameattachment mechanism adapted to attach to a Bookwalter®, Omni®, andSynthes® frame, respectively, and which may include a swivel mechanismto allow the transplant sleeve to be raised, lowered, or swiveled fromside to side.

FIG. 3 illustrates one embodiment of the present invention, featuring aslideable bottom locking mechanism.

FIG. 4 illustrates a cut-away view of one embodiment of the presentinvention, featuring a cold pack pouch and interior padding, as well asa flexible sleeve structure.

FIG. 5 illustrates a cross-sectional, partially exploded view of oneembodiment of the present invention.

It will be appreciated that the drawings are illustrative and notlimiting of the scope of the invention which is defined by the appendedclaims. The various elements of the invention accomplish various aspectsand objects of the invention. It is appreciated that not every elementof the invention can be clearly displayed in a single drawing, and assuch not every drawing shows each element of the invention.

DETAILED DESCRIPTION

The drawings will now be discussed in reference to the numerals providedtherein so as to enable one skilled in the art to practice the presentinvention. The drawings and descriptions are exemplary of variousaspects of the invention and are not intended to narrow the scope of theappended claims. It will be appreciated that the various aspects of thesuspended organ transplant systems discussed herein may be the same.Different reference numerals may be used to describe similar structuresin the various suspended organ transplant systems for clarity purposesonly.

Various aspects of the invention and accompanying drawings will now bediscussed in reference to the numerals provided therein so as to enableone skilled in the art to practice the present invention. The skilledartisan will understand, however, that the methods described below canbe practiced without employing these specific details, or that they canbe used for purposes other than those described herein. Indeed, they canbe modified and can be used in conjunction with products and techniquesknown to those of skill in the art in light of the present disclosure.Furthermore, it will be appreciated that the drawings may show aspectsof the invention in isolation and the elements in one figure may be usedin conjunction with elements shown in other figures.

Reference in the specification to “one configuration,” “one embodiment”“one aspect” or “a configuration,” “an embodiment” or “an aspect” meansthat a particular feature, structure, or characteristic described inconnection with the configuration may be included in at least oneconfiguration and not that any particular configuration is required tohave a particular feature, structure or characteristic described hereinunless set forth in the claim. The appearances of the phrase “in oneconfiguration” or similar phrases in various places in the specificationare not necessarily all referring to the same configuration, and may notnecessarily limit the inclusion of a particular element of the inventionto a single configuration, rather the element may be included in otheror all configurations discussed herein. Thus it will be appreciated thatthe claims are not intended to be limited by the representativeconfigurations shown herein. Rather, the various representativeconfigurations are simply provided to help one of ordinary skill in theart to practice the inventive concepts claimed herein.

Furthermore, the described features, structures, or characteristics ofembodiments of the present disclosure may be combined in any suitablemanner in one or more embodiments. In the following description,numerous specific details may be provided, such as examples of productsor manufacturing techniques that may be used, to provide a thoroughunderstanding of embodiments of the invention. One skilled in therelevant art will recognize, however, that embodiments discussed in thedisclosure may be practiced without one or more of the specific details,or with other methods, components, materials, and so forth. In otherinstances, well-known structures, materials, or operations may not beshown or described in detail to avoid obscuring aspects of theinvention.

Before the present invention is disclosed and described in detail, itshould be understood that the present invention is not limited to anyparticular structures, process steps, or materials discussed ordisclosed herein. More specifically, the invention is defined by theterms set forth in the claims. It should also be understood thatterminology contained herein is used for the purpose of describingparticular aspects of the invention only and is not intended to limitthe invention to the aspects or embodiments shown unless expresslyindicated as such. Likewise, the discussion of any particular aspect ofthe invention is not to be understood as a requirement that such aspectis required to be present apart from an express inclusion of that aspectin the claims.

It should also be noted that, as used in this specification and theappended claims, singular forms such as “a,” “an,” and “the” may includethe plural unless the context clearly dictates otherwise. Thus, forexample, reference to “a bracket” may include an embodiment having oneor more of such brackets, and reference to “the target plate” mayinclude reference to one or more of such target plates.

As used herein, the term “substantially” refers to the complete ornearly complete extent or degree of an action, characteristic, property,state, structure, item, or result to function as indicated. For example,an object that is “substantially” enclosed would mean that the object iseither completely enclosed or nearly completely enclosed. The exactallowable degree of deviation from absolute completeness may in somecases depend on the specific context, such that enclosing the nearly allof the length of a lumen would be substantially enclosed, even if thedistal end of the structure enclosing the lumen had a slit or channelformed along a portion thereof. The use of “substantially” is equallyapplicable when used in a negative connotation to refer to the completeor near complete lack of an action, characteristic, property, state,structure, item, or result. For example, structure which is“substantially free of” a bottom would either completely lack a bottomor so nearly completely lack a bottom that the effect would beeffectively the same as if it completely lacked a bottom.

As used herein, the term “about” is used to provide flexibility to anumerical range endpoint by providing that a given value may be “alittle above” or “a little below” the endpoint while still accomplishingthe function associated with the range.

As used herein, a plurality of items, structural elements, compositionalelements, and/or materials may be presented in a common list forconvenience. However, these lists should be construed as though eachmember of the list is individually identified as a separate and uniquemember.

Concentrations, amounts, proportions and other numerical data may beexpressed or presented herein in a range format. It is to be understoodthat such a range format is used merely for convenience and brevity andthus should be interpreted flexibly to include not only the numericalvalues explicitly recited as the limits of the range, but also toinclude all the individual numerical values or sub-ranges encompassedwithin that range as if each numerical value and sub-range is explicitlyrecited. As an illustration, a numerical range of “about 1 to about 5”should be interpreted to include not only the explicitly recited valuesof about 1 to about 5, but also include individual values and sub-rangeswithin the indicated range. Thus, included in this numerical range areindividual values such as 2, 3, and 4 and sub-ranges such as from 1-3,from 2-4, and from 3-5, etc., as well as 1, 2, 3, 4, and 5,individually. This same principle applies to ranges reciting only onenumerical value as a minimum or a maximum. Furthermore, such aninterpretation should apply regardless of the breadth of the range orthe characteristics being described.

The invention and accompanying drawings will now be discussed inreference to the numerals provided therein so as to enable one skilledin the art to practice the present invention. The drawings anddescriptions are intended to be exemplary of various aspects of theinvention and are not intended to narrow the scope of the appendedclaims. Furthermore, it will be appreciated that the drawings may showaspects of the invention in isolation and the elements in one figure maybe used in conjunction with elements shown in other figures.

Turning to FIG. 1, there is shown a front view of a suspendable organtransplant container, according to principles of the present invention.The transplant container may be sleeve-like in that it forms a case intowhich the organ to be transplanted fits. Thus, for convenience, thecontainer will be generally referred to as a transplant sleeve, and isgenerally indicated at 1. The transplant sleeve 1 may include aconnector mechanism 4. The connector mechanism 4 may be adapted to hookonto a surgical frame (not shown) placed around the patent. The surgicalframe may be, for example, a Bookwalter® (Symmetry Surgical, Antioch,Tenn.) frame or any other surgical frame known to one of skill in theart, commonly used during a surgery to hold an incision open or toperform other surgical tasks.

The connector mechanism 4 may include a swivel 8, allowing thetransplant sleeve 1 to be rotated to permit the surgeon to suture oneither side of the organ.

The transplant sleeve 1 may be closed at the top with a clamp 12. Theclamp may be, for example, a magnetic strip, an operable clamp, or barinto which the transplant sleeve 1 can be slid.

The transplant sleeve 1 further comprises a main body 15 and a port ormain body opening 30, positioned to facilitate access to the veins,arteries, ducts, and other attachment portions of an organ (not shown.)In some embodiments, the accessible port(s) 30 may be located in thecenter of the bottom end, allowing the organ's veins, arteries, and anyother organ attachments to dangle down for easy access through thetransplant sleeve 1. In other embodiments, the accessible opening(s) 30may be fixed to a size suitable to allow access to the organ's veins,arteries or other necessary attachment points. In some embodiments, theoperable ports 30 can be partly opened, enlarging the accessible openingto allow for easier access to the organ attachment points for differentorgans.

The main body or vessel 15 of the transplant sleeve 1 may be flexible inorder to accommodate organs of varying sizes, or may be somewhat rigidin order to form an interior void or organ cavity adapted to receive anorgan of a particular size and protect it from being bumped or otherwiseinjured. The main body 15 may be transparent in order to facilitate avisual check of the organ.

One advantage of the present invention is that, in some embodiments, themain body 15 can withstand being immersed in preservation solution forat least several hours. Thus, the organ can be harvested, placed in thetransplant sleeve 1, and then the transplant sleeve 1 can be immediatelypackaged in chilled preservation solution prior to transport. Thus, theamount of manipulation of the organ between harvest and implantationsurgery can be minimized.

In the embodiment shown in FIG. 1, the port openings 30 are positionedon the sides of the main body 15, and are operably openable by sliders34 similar to those used along the top of ZIPLOC® bags. The sliders 34can be placed in a closed position while the organ is transported, inorder to protect the veins, arteries, ducts, and other attachment pointsof the organ. When each attachment point is needed for grafting, theport 30 can be opened with the slider 34, permitting access to theattachment point. Thus, the ports 30 permit access to the organ to becontained within the main body 15, through which transplant surgeons orother medical personnel may access the arteries, veins, and otherfeatures of an organ while the organ remains in the transplant sleeve 1.

It will be appreciated that the port 30 need not be opened with a slider34;

rather, the port 30 may be held closed with a tearable perforation, apatch of hook-and-loop material, releaseable adhesive, or any otherreversible means of attachment known to one of skill in the art. Theport 30 may be left open during organ transport, if desired. Theindividual ports 30 may also be labeled or colored, in order to indicatethe orientation of the organ contained within the main body 15. Forexample, the port 30 positioned closest to a duct may be colored greento differentiate it from the port 30 positioned closest to an artery,and the like.

The main body 15 of the transplant sleeve 1 may also be equipped with acold pack pocket 40. A cold pack pocket 40 may be present on one side ofthe suspendable organ transplant sleeve 1, may wrap around the organtransplant sleeve 1, or a cold pack pocket 40 may be located on bothsides of the main body 15. In some embodiments, the pocket or pockets 40are integral and contain saline or other fluid capable of chilling andcushioning an organ. In other embodiments the pocket 40 may have a coldpack opening 44, so that a cold pack (not shown) may be inserted orremoved as necessary to maintain optimal organ temperature.

In some embodiments, the main body 15 of the transplant sleeve 1includes a temperature indicator 48. The temperature indicator 48 may bea visual indicator, or may be a network-enabled sensor, which enables auser to track the temperature of an organ remotely, or while the organis being transported.

In the pictured embodiment, the bottom portion 60 of the sleeve 1 isclosed, in order to provide a drip reservoir, thus preventing the organfrom dripping into an incision during transplant.

In the pictured embodiment, the main body 15 of the transplant sleeve 1is interrupted by a tearable perforation 65 which connects each port 30.Thus, after an organ has been fully sutured into place, the organtransplant sleeve 1 may be easily pulled apart, releasing the organwithout disturbing any of the sutures. The tearable perforation 65 maybe located on only one side of the main body 15, and thus when thetearable perforation 65 is pulled apart, the suspendable organtransplant sleeve 1 will still be a single piece of material. This hasthe advantage of minimizing the number and variety of equipment neededfor an organ transplant surgery, and reducing the labor required toconfirm and count all remaining equipment, after the transplant surgeryis completed.

In other embodiments, the transplant sleeve 1 may be disposable,reducing storage and sterilization costs.

In yet other embodiments, the main body 15 may be sized and shapedappropriately for a human kidney, or may be shaped to receive a varietyof sizes of organs.

Now turning to FIGS. 2A, 2B, and 2C, there are shown severalrepresentative embodiments of connector mechanisms 4A, 4B, 4C, which maybe used to suspend the organ transplant sleeve (not shown) from asurgical frame at a desired height. Connector mechanisms may be equippedwith a swivel 8, so that the organ transplant sleeve may be turned toallow a surgeon to suture on either side of the organ. In theillustrated embodiments, the connector mechanism is adjustable, suchthat the organ can be releasably attached at a range of elevations abovethe surgical incision.

Turning to FIG. 2A specifically, a connector mechanism 4A may includeratcheting protrusions 5 which allow an organ transplant sleeve to befreely positioned on a frame with matching protrustions and clamps, suchas a Bookwalter® frame.

In some embodiments, such as FIG. 2B, a connector mechanism 4B mayinclude an integral clamp 9 and a slotted rod 6. Protrusions on a framefit into the slotted rod 6. The integral clamp 9 can be tightened tocompress the slotted rod 6 to engage the portion of the frame heldwithin the slotted rod 6, thus holding it in place.

In some embodiments, the connector mechanism 4C may be a simple hookedrod 7, which can be hooked over a surgical frame. In such an embodiment,padded arms 10 may clamp around the hooked rod 7, and can be tightenedor loosened by means of an integral screw 9. Regardless of whichspecific embodiment is used, the connector mechanisms 4A, 4B or 4C allowthe transplant sleeve 1 to be held adjacent the transplant site tominimize the amount of handling to which the organ is subjected.

Turning now to FIG. 3, there is shown a slightly-angled view of asuspendable organ transplant sleeve, generally indicated at 1. In thepictured embodiment, the connector mechanism 4 is a simple handle orloop. The main body 15 is comprised of outer walls 20 which are joinedtogether at a top joint 18. The top joint 18 is adapted to fit the clamp12. In the present embodiment, the clamp 12 is a u-shaped holder withopen ends, and the top joint 18 is thickened, so that the clamp 12 maybe slid onto the top joint 18. Once in place, the suspendable organtransplant sleeve 1 cannot fall out of the clamp 12, because thethickness of the top joint 18 is too great to slip downwards out of theclamp 12.

As shown in FIG. 3, the organ transplant sleeve 1 may have a single portopening 30. The entire bottom may be openable to release the organ, onceit is sutured into place, by drawing sliders 34 along closure tracks 62.It will be appreciated that any equivalent means of reversibly sealingthe organ transplant sleeve 1 known to one of skill in the art may beemployed, such as a perforated line, a releaseable adhesive, and thelike. It will also be appreciated that irreversible configurations mayalso be used in some situations.

Also shown is the cold pack pocket 40—in this case, the pocket 40 isshaped to receive a replaceable cold pack (not shown) which may beremoved, chilled, and inserted again. In use a doctor or other healthcare professional takes an organ which is to be transplanted and placesthe organ within a void formed by the material forming the main body 15of the transplant sleeve. This may be accomplished through an opening atthe top which is later closed or through another opening in the body. Itis preferred that the main body 15 is configured to allow disposition ofthe organ therein with minimal handling of the organ. Whatever openingis used to dispose the organ inside the main body 15 is then closed anda cooling agent may be added if not already present. The organ is thenready for transport. Once in the operating room with the patient whowill be receiving the organ, one or more of the openings may be openedto provide access to the organ while the transplant sleeve remainsholding the organ, thereby minimizing potential injury to the organ.Once part of all of the veins and ducts are attached, the transplantsleeve 1 may be opened so as to allow the remainder of the organ to beremoved from the sleeve.

Turning now to FIG. 4, there is shown a, cut-away view of an organtransplant sleeve, generally indicated at 1′. In the present embodiment,main body 15 is formed in part by outer walls 20 which are thickened atthe top to to form the top joint 18, which may be slid into the clamp 12to selectively close the opening at the top of the sleeve 1′ into whichthe organ is originally placed.

In the present embodiment, the outer walls 20 are somewhat stiffened,such that the void between the outer walls forms an organ cavity 25. Thesize of organ cavity 25 may be adapted to fit, for example, a mammal'skidney, heart, liver, or other organ requiring transplant.

As shown, the organ cavity 25 is padded by padded inner walls 22. Thepadded inner walls 22 may be insulated in order to keep the organoptimally chilled. The padded inner walls 22 may be filled with air orsaline, and in some embodiments the inflation of the padded inner walls22 may be adjusted after insertion of an organ, in order to prevent theorgan from shifting during transport and surgery.

As shown, the padded internal walls 22 and the shaped external walls 20cause the organ cavity 25 to narrow near the bottom. This has theadvantage of preventing an organ placed within from slipping downwardswhile the organ transplant sleeve 1 is suspended from a surgical rack(not shown.)

In the present embodiment, the cold pack pocket 40 may be an integral,closed, and recirculating chamber. The cold pack pocket may contain, forexample, a chilled liquid or thin gel 42 which circulates viacirculating tubes 46. Tubes 46 may be detachable, for example withtwist-style luer lock adapters 48. The advantage therein is that thetubes 46 may be detached during organ transport. When the organ sleeve 1is hung on a surgical rack for transplant, or if the surgery becomeslengthier than normal, the tubes 46 may be attached and chilled fluidmay be circulated in order to maintain optimum organ temperature.

Also as shown in FIG. 4, the bottom of the organ transplant sleeve maybe opened via pull slides or one or more port slides 34, drawn alongclosure tracks 62, thus releasing the organ. In such a manner, the organis carefully held during transport and during the initial stages ofimplantation, while being easy for the surgeon to access.

FIG. 5 illustrates a cross-sectional view of an organ transplant sleeve,generally indicated at 1, with the clamp (not shown) removed. The outerwalls 20 may be formed in essentially two pieces joined along the sides,or by a single piece of material. The material may be open at the topbut closeable by a top joint 18, and at the bottom by closure tracks 62.The top joint 18 may be constructed, for example, out of a deformableplastic, so that the two halves may be pressed tightly together. It willbe appreciated that the two outer walls 20 may also be joined at the topby irreversible means, such as adhesive, ultrasonic welding or any othermeans known to one of skill in the art.

It is advantageous if the outer walls 20 are secured together at the topjoint 18 immediately after the organ is harvested and placed inside,thus substantially preventing bacteria, fungi, and/or other contaminantsfrom contacting the organ during both transport and recipient surgery.In some embodiments (FIG. 4, for example) the outer walls 20 arepermanently attached at the top joint 18. In such embodiments, aharvested organ may be inserted by unzipping the closure tracks 62 atthe bottom of the sleeve, inserting the organ, and zipping the closuretracks 62 into a closed position.

When joined at the bottom, the closure tracks 62 form a rail over whicha port slider or pull tab (shown in FIG. 1 at 34) may be drawn in orderto close or open the bottom.

Also shown are padded internal walls 22, and a cold pack pocket 40 oneither side of the organ transplant sleeve 1. In the present embodiment,the cold pack pockets 40 are shaped to receive a removeable cold pack50. The cold pack 50 may be, for example, a flexible plastic packet ofice, saline, vinyl-coated silica gel, hydroxyethyl cellulose, or othernon-toxic refrigerant. It is advantageous if the outer walls 20 are atleast partially rigid, so that the cold pack 50 may be inserted orwithdrawn without disturbing the placement of an organ in the organcavity 25.

In some embodiments, the top joint 18 may be pre-sealed and the externalwalls 20 may be substantially soft and flexible, to form a chilledpocket, which may be placed inside a body cavity to chill an organin-situ during surgery.

While the various aspects of the invention are discussed with respect toindividual embodiments, it will be appreciated that various aspects ofone embodiment may be used with other embodiments and have been omittedfor brevity. It will be appreciated further that various combinationsmay be made of the various embodiments discussed above. Thus, forexample, in accordance with the teachings herein, an organ transplantcontainer may include a transplant sleeve having a main body and atleast one selectively closeable opening; and a connector attached to thetransplant sleeve, the connector configured for attachment to a surgicalframe. The transplant container may further include: the main bodyhaving a single wall vessel with an openable top end for inserting theorgan into the main body, and a bottom end having at least oneselectively openable opening disposed adjacent thereto for removing anorgan from the main body; the main body having a top end having anopening for receiving an organ and a bottom end being openable torelease the organ; the main body having a plurality of openings foraccessing different parts of an organ when an organ is disposed in themain body; the main body being shaped to conform to a human kidney; atleast one selectively openable opening disposed adjacent the bottom endhas a series of perforations; at least one selectively openable openingdisposed adjacent the bottom end having a slideable closure device; theat least one selectively openable opening being disposed adjacent thebottom end comprises a magnetic strip; the connector having a portion ofa ratchet for retaining the transport sleet on a surgical frame; theconnector having a swivel bearing permits the transplant sleeve to beswiveled while still hooked to a surgical frame; the transplant sleevehaving a pocket for receiving a cooling material to thereby regulatetemperature in the main body; the main body having a top and a bottomand wherein at least one selectively openable opening comprises anopening in the bottom of the main body; at least one selectivelyopenable opening being located on a side of the main body; the main bodyfurther comprises cushioning material; main body having an inner wallattached to an outer wall, the inner wall being adapted to insulate anorgan; and/or further having a temperature indicator located on the mainbody, and combinations thereof.

Likewise, a method of transporting and transplanting an organ mayinclude: receiving a transplant sleeve having an organ disposed therein;attaching the transplant sleeve to a surgical frame; opening at leastone selectable opening in the transplant sleeve to expose a vein or ductof the organ; and attaching the vein or duct to the patient while theorgan remains in the transplant sleeve. The method may further includethe transplant sleeve having a plurality of selectably openableopenings; and/or opening a bottom portion of the transplant sleeve torelease the organ from the transplant sleeve.

Thus there is disclosed a suspendable organ transplant sleeve system andmethods of using the same. It will be appreciated that numerousmodifications may be made without departing from the scope and spirit ofthis disclosure. The appended claims are intended to cover suchmodifications.

What is claimed is:
 1. An organ transplant container comprising: atransplant sleeve having a main body, at least one selectively closeableopening, and a temperature indicator located on the main body; and aconnector attached to the transplant sleeve, the connector configuredfor attachment to a surgical frame.
 2. The organ transplant container ofclaim 1, wherein the main body comprises a top end having an opening forreceiving an organ and a bottom end having a selectively openableopening to release the organ.
 3. The organ transplant container of claim2, wherein the main body comprises a selectively openable port foraccessing a vein or a duct of an organ when an organ is disposed in themain body.
 4. The organ transplant container of claim 1, wherein themain body is shaped to conform to a human kidney.
 5. The organtransplant container of claim 2, wherein the selectively openableopening to release the organ comprises a series of perforations.
 6. Theorgan transplant container of claim 2, wherein the selectively openableopening to release the organ comprises a slideable closure device. 7.The organ transplant container of claim 2, wherein the selectivelyopenable opening to release the organ comprises a magnetic strip.
 8. Theorgan transplant container of claim 1, wherein the connector comprises aportion of a ratchet for retaining the transplant container on asurgical frame.
 9. The organ transplant container of claim 1, whereinthe connector comprises a swivel bearing to permit the transplant sleeveto be swiveled while still hooked to a surgical frame.
 10. The organtransplant container of claim 1, wherein the transplant sleeve comprisesa pocket for receiving a cooling material to thereby regulatetemperature in the main body.
 11. The organ transplant container ofclaim 1, wherein the at least one selectively closeable opening islocated on a side of the main body.
 12. The organ transplant containerof claim 1 wherein the main body further comprises cushioning material.13. The organ transplant container of claim 1, wherein the main bodycomprises an inner wall attached to an outer wall, the inner wall beingadapted to insulate an organ.
 14. An organ transplant containercomprising: a transplant sleeve having a main body, wherein the mainbody comprises a top end having an opening for receiving an organ and abottom end being openable to release the organ, and at least oneselectively openable port for accessing a vein or a duct of an organwhen an organ is disposed in the main body; and a connector attached tothe transplant sleeve, the connector configured for attachment to asurgical frame.
 15. The transplant container of claim 14, wherein thebottom end and the at least one selectively openable port are connectedsuch that when the bottom end is opened the port is also opened torelease the organ and vein or duct.
 16. The transplant container ofclaim 14, wherein the transplant sleeve comprises a pocket for receivinga cooling material to thereby regulate temperature in the main body. 17.An organ transplant container comprising: a transplant sleeve having amain body, at least one selectively closeable opening, the main bodyfurther comprising cushioning material; and a connector attached to thetransplant sleeve, the connector configured for attachment to a surgicalframe.
 18. The organ transplant container of claim 17, wherein the mainbody comprises a top end having an opening for receiving an organ and abottom end being openable to release the organ.
 19. The organ transplantcontainer of claim 17, wherein the transplant sleeve comprises a pocketfor receiving a cooling material to thereby regulate temperature in themain body.
 20. The organ transplant container of claim 17, wherein thetransplant sleeve comprises an inner wall attached to an outer wall, theinner wall being adapted to insulate an organ.